parallel randomized trial

NCT00775684

A Randomized, Controlled Trial Comparing the Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass in Patients With Impaired Fasting Glucose or Early Type 2 Diabetes

Type 2 diabetes (adults)NCT00775684S000051

Design

Randomized: 47
Start year: 2008
Treatment: 26.07 weeks
Countries: United States
Sponsor: University of Pennsylvania (non industry)
Eligibility: age 18 to 70; fasting glucose 110 to 159 mg/dL off glucose lowering drugs; early T2D or impaired fasting glucose

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	none; lifestyle: not reported	17	14
A2	Sitagliptin Sitagliptin	none; lifestyle: not reported	13	12
A3	Glimepiride Glimepiride	none; lifestyle: not reported	17	14

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Sitagliptin A2	Glimepiride A3
age	mean (years)	57	57	52
age	se (years)	2	3	3
black	percent	50	42	64
bmi	mean (kg/m2)	33	33	31
bmi	se (kg/m2)	2	1	2
diabetes duration	mean (years)	3.3	5.3	3.4
diabetes duration	se (years)	0.6	1.7	0.9
female	n	6	4	7
female	percent	36	33	43
hba1c	mean (percent)	6.4	6.5	6.7
hba1c	se (percent)	0.1	0.1	0.1

Analyses this trial contributes to

Results

10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	change	-0.2 percent	0.1	14	not stated; completers; R0023972:Table 1
26.07	A2	change	-0.01 percent	0.1	12	not stated; completers; R0023972:Table 1
26.07	A3	change	-0.5 percent	0.2	14	not stated; completers; R0023972:Table 1

Body weight change in kilograms (diabetes) (1 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26.07	A1	change	-2.6 kg	0.8		14	not stated; completers; R0023972:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 17	not stated; randomized; registry:adverse_events
A2	events	0 / 13	not stated; randomized; registry:adverse_events
A3	events	0 / 17	not stated; randomized; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 17	not stated; randomized; registry:adverse_events
A2	events	0 / 13	not stated; randomized; registry:adverse_events
A3	events	0 / 17	not stated; randomized; registry:adverse_events